Device Recall Oxygen Mask

  • Model / Serial
    Lot Number 100721, 100733, 104106, 104798, 109824
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number 100454, 100734, 101053, 101121, 101607, 101665, 101999, 102352, 102726, 102766, 102785, 103179, 103254, 103529, 104103, 104457, 104653, 104706, 104799, 105213, 105283, 105315, 105451, 105676, 109186
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
  • Manufacturer
  • Model / Serial
    Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
  • Manufacturer
  • Model / Serial
    Lot Number  100163, 100464, 101671, 102011, 102397, 102787, 102856, 103850, 104901
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
  • Manufacturer
  • Model / Serial
    Lot Number 100272, 100465, 101132, 101616, 101994, 102398, 102788, 102935, 103192, 103384, 103445, 103851, 103908, 104078, 104902, 104947, 105189, 105441, 105935
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
  • Manufacturer
  • Model / Serial
    Lot Number  (Product Code 3224-E) 105215; (Product Code 3226-E) 100497, 100748, 101140, 102282, 102400, 102727, 102858, 103188, 103273, 103300, 103853, 104081, 104654, 104889, 105065, 105190, 105216, 13-34
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
  • Manufacturer
3 more